Kornimate/medical-research-clean huggingface dataset:
the comparison of postoperative pain after colon resection in intravenous patient-controlled analgesia between conventional mode and optimizing b.i mode with 'painstop' equipment

Conditions: Colon Cancer

Summary: colon resection is one of the major surgery, the postoperative pain is so severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (pca). the most common pain management of this surgery is the intravenous (iv) pca. if it is relatively insufficient amount of narcotic analgesics ,in the case of iv pca, may be failed to reduce the pain effectively. consequently, it may result in the a lot of rescue analgesics use, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. and the patient's satisfaction to the pca may be low. for the recently released pca instrument 'painstop', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (lot). furthermore, this device can be set to optimize basal infusion (b.i), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. therefore, this pca device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. however, since there are few studies related to this new mode of pca, more research is needed in patients with postoperative pain.


Eligibility criteria:
inclusion criteria: 1. the subjects who undergoing colon resection due to colon cancer 2. asa class ⅰ-ⅲ 3. written consents obtained to participate voluntarily in this clinical trial exclusion criteria: 1. sudden change of surgical plan 2. patients who have the hypersensitivity to the pain killers including narcotics 3. patients who are unable to express the degree of pain

Keywords: colon resection patient controlled analgesia optimizing basal infusion mode
pizza-salami study in children and adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the pizza-salami-study aims to investigate the efficacy of carbohydrate plus fat/protein (cfp) counting compared with carbohydrate (carb) counting using normal and dual-wave bolus in sensor-augmented pump therapy in children and adolescents with type 1 diabetes. for fat/protein counting the model used by pankowska et al. will be applied.

this is a prospective, international multi-centre, open randomized clinical trial to assess whether the use of paradigm real-time system from the onset of type 1 diabetes (t1d) leads to a better glycaemic control after 12 months of t1d compared with the use of paradigm 515/715 insulin pump combined with conventional self-monitoring blood glucose finger-sticks in paediatric patients. total randomized treatment duration of the study for a patient will be 12 months with an optional phase of follow-up of 3 months.patients eligible according to inclusion and exclusion criteria will be randomized to one of the two treatment groups. a total of 160 patients will be recruited. each subject will participate in the study for 15 months, which includes 12 months of treatment and 3 months of follow-up. each patient is asked to use either the paradigm real-time system that provides a combination of insulin pump and the real-time continuous glucose monitoring or paradigm 515/715 insulin pump combined to conventional smbg finger-sticks. main time-points of assessments are at baseline (within one month after t1d onset) and 12 months thereafter. in total, there will be 6 study visits at the local site. during study, patients will regularly attend the outpatient clinic according to local standard care, i.e. every 8±2 weeks.

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes * age 6 - 21 years * diabetes duration \> 1 year * treatment with pump therapy (csii) \> 3 months * written informed consent by patients and parents * patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day * patients must be willing to performed all study procedures exclusion criteria: * language barriers * eating disorders * pregnancy * drug abuse * patient refutes participation or study procedures

Keywords: csii prandial insulin requirements bolus calculation dual-wave bolus
integrating food rx with best feeding practices with efnep

Conditions: Dietary Habits; Childhood Obesity; Food Selection; Feeding Behavior

Summary: to assess feasibility and acceptability of of integrating food rx and best feeding practices with efnep participants via a pilot study.

the purpose of the pilot study is to test the ffyf feeding curriculum material and procedures for implementation, staff training, recruitment, and data collection.

Eligibility criteria:
inclusion criteria: * living in harris or fort bend counties * being a parent of a child 4-8 years old * ability to speak in english or spanish * have ready access to a telephone * have access to the internet with a smart phone, a tablet, a laptop, or a desktop computer exclusion criteria: * parents of children with disabilities and/or those on prescription medications that affect weight and/or appetite * parents who are not able to complete self-report questionnaires
neuroimaging of donor iron deficient study

Conditions: Iron Deficiency

Summary: this pilot study is designed to investigate (1) whether getting iron treatment affects iron in the brain and (2) how getting iron treatment affects brain functions when it is performing specific cognitive tasks. by cognitive tasks, it means tasks that involve perceiving, representing, or assessing things. the specific cognitive tasks used here will involve tests of memory and processing speed.

iron, the most abundant metal in the brain, is vital for multiple cellular processes, including neurotransmitter synthesis, neuron myelination, and mitochondrial function. in the united states, of the donors who provided the \~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. this study is to collect data through noninvasive procedures routinely employed in clinical practice to better understand how iron treatment may affect brain functions.

Eligibility criteria:
inclusion criteria: * current participant of the associated randomized controlled trial conducted at columbia university medical center (therefore invited to participate in this optional ancillary study). exclusion criteria: * not a current participant of the associated randomized controlled trial conducted at columbia university medical center.

Keywords: iron repletion blood donation transfusion
clinical trial on the articular pain with a cucumber supplement in patients diagnosed with arthrosis

Conditions: Osteoarthritis

Summary: randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.

the subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Eligibility criteria:
inclusion criteria: * age over 40 years. * subjects diagnosed with osteoarthritis with functional grades i-iii according to the modified criteria of the american college of rheumatology. * subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the vas pain assessment. * subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment. exclusion criteria: * serious or terminal illnesses. * subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health. * subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, paget's disease, chronic pain syndrome, etc.). * subjects with a body mass index above 32. * pregnant or lactating women. * inability to understand informed consent.
individualized and combined effects of diabetes and smoking on the antiplatelet activity of ticagrelor in acute myocardial infarction patients undergoing primary pci

Conditions: Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention

Summary: background:diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary pci. objective: compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary pci. methods: sixty patients were recruited in this study. patients were allocated to one of four groups according to the diabetes and smoking status. non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. all patients received 180 mg ticagrelor before pci. platelet reactivity index(pri) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. pri and/or mpa values \> 50% were defined as high platelet reactivity.


Eligibility criteria:
inclusion criteria: acute coronary syndrome (acs) undergoing pci exclusion criteria: patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong cyp inducers or inhibitors, and/or severe liver disorders were excluded from the study. patients with previous history of coronary artery disease, previous pci or patients administering other antiplatelets were excluded from the current study.
onset of action of mometasone furoate (mk-0887/sch 032088) nasal spray compared with placebo in seasonal allergic rhinitis (c93-184)

Conditions: Rhinitis, Allergic, Seasonal

Summary: this study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (mk-0887/sch 032088) 200 mcg administered once daily compared with placebo for 14 days.


Eligibility criteria:
inclusion criteria: * has a 2-year history of seasonal allergic rhinitis * has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year) * is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis exclusion criteria: * women who are pregnant or breastfeeding * women of childbearing potential who are not using an acceptable form of birth control * has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil * has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study * is on immunotherapy with the exception of maintenance therapy * has a clinically significant upper respiratory or sinus infection * has used an investigational drug within the previous 30 days * has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow * has a history of multiple drug allergies or an allergy to antihistamines or corticoids * has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator * has rhinitis medicamentosa * is using of any chronic medication which could affect the course of seasonal allergic rhinitis
safety and immunogenicity of gsk biologicals' investigational malaria vaccine in hiv infected infants and children

Conditions: Malaria

Summary: the purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in hiv-infected infants and children

this protocol posting has been updated due to protocol amendment 2.

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * a male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination. * signed or thumb-printed informed consent obtained from the parent(s)/lar(s) of the infant or child. where parents/lars are illiterate, the consent form will be countersigned by a witness. * subjects who the investigator believes that their parents/lars can and will comply with the requirements of the protocol should be enrolled in the study. * subjects who are known to be hiv-infected (documented positive dna pcr), whether taking hiv antiretroviral treatment (art) or not. * subjects who are born following a normal gestation period. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: * acute disease at the time of enrolment. however, the presence of an illness listed as grade i or grade ii (who pediatric aids clinical staging) will not of itself constitute an exclusion criterion. enrolment should be deferred if axillary temperature is \>=37.5°c. * grade iii or grade iv abnormality on screening laboratory blood sample. * grade iii or iv aids at the time of enrolment (who pediatric aids clinical staging). * major congenital defects. * planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding dose°1 of study vaccine, or planned use during the study period. * previous participation in any other malaria vaccine trial. * simultaneous participation in another clinical trial including administration of experimental treatment. * same sex twins. * history of allergic reactions (significant ige-mediated events) or anaphylaxis to previous immunizations. * history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. * child in care.

Keywords: plasmodium falciparum schedule hiv malaria vaccine epi africa
use of a remifentanil-propofol mixture in patients undergoing breast cancer surgery

Conditions: Anesthetics; Remifentanil; Propofol

Summary: co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. however, delivery of remifentanil-propofol mixture by target-controlled infusion(tci) for general anesthesia in surgical procedure has not been described. breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. this pilot study was to examine the merit of remifentanil-propofol mixture as a ga regimen for breast cancer surgery.

previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.

Eligibility criteria:
inclusion criteria: * asa ii or iii * age more than 18 years * scheduled for breast cancer surgery under general anesthesia. exclusion criteria: * previously allergic to propofol or remifentanil * combining other surgical procedure leading to extended operative time

Keywords: propofol remifentanil total intravenous anesthesia breast surgery
assessment of peripheral endothelial function in idiopathic pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: the aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (ipf) and the relationship between the peripheral endothelial function and the severity of the ipf.

the primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). the pulmonary function will be assessed by the measures of the forced expiratory volume at one second (fev1), the forced vital capacity (fvc) and the total lung capacity (tlc) and the diffusing capacity of the lung for carbon monoxide (dlco). the dyspnea will be assessed with the new york heart association (nyha) score. the exercise capacity will be assessed by the 6-min walk test. pulmonary arterial pressure will be recorded through cardiac echography or catheterization.

Eligibility criteria:
inclusion criteria: * ipf according to ats/ers 2011's criteria * stable ipf (no reduction of fvc or dlco of more than 10% and 15% respectively) exclusion criteria: * patients with a significant disease other than ipf. a significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial. * pregnant or nursing women. * non-pulmonary fibrosis * treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function

Keywords: endothelial function, idiopathic pulmonary fibrosis
berodual® respimat® solution for inhalation in patients with chronic obstructive airways disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: tolerability, efficacy and handling of berodual® respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility criteria:
inclusion criteria: * men and women presenting with the symptoms of chronic obstructive airways disease were given berodual® respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms * patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with berodual® metered dose inhaler (mdi) or other respiratory medications prior to the post-marketing surveillance study could be included exclusion criteria: * patients presenting with the general and specific contraindications listed in the patient information leaflet and the basic product information
evaluate the auxiliary diagnostic value of circulating tumor cells in benign and malignant lung nodules

Conditions: Solitary Pulmonary Nodule

Summary: by testing the ctc number of new solitary pulmonary nodule patient, evaluating the correlation of ctc number and benign and malignant lung nodules auxiliary diagnosis, the correlation of ctc number and the size of lung nodules of the malignant patients, the correlation between the ctc number and subtypes of malignant lung nodules patients.the ctc and tumor markers will be detected before the patient received treatment. tumor markers include pro-grp, nse, cea, cyfra211, scc.


Eligibility criteria:
inclusion criteria: * new solitary pulmonary nodule patients * first visit patient * heart, liver and kidney function is normal. * 18-80 years old. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * blood collection time is not in the scheduled time. * the plasma sample hemolysis or condensation. * whole blood samples less than 3 ml. * poor compliance

Keywords: ctc pcr
nilotinib ± peg-ifn for first line chronic phase cml patients

Conditions: Chronic Myeloid Leukemia

Summary: this is a phase iii trial comparing, for newly diagnosed chronic phase cml patients, nilotinib 600 mg bid as a standard arm and nilotinib 600 mg bid combined to interferon alfa 2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for a total of 24 months of combination, in a 1:1 randomized manner. the assessment for the primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is the rate patients obtaining mr4.5 will be measured at this time point.


Eligibility criteria:
inclusion criteria: * male and female patients * cp-cml, positive philadelphia chromosome or positive bcr-abl (m-bcr transcript), diagnosed less than 3 months prior to study entry * age of at least 18 years-old and less than 65 years * patient for whom treatment with nilotinib is expected * no other cml treatment except for hydroxyurea and/or anagrelide * no previous tki treatment. * no previous treatment with ifn even for other purposes. * sgot and sgpt \< 2.5 unl * serum creatinine \< 2 unl * no planned allogeneic stem cell transplantation * signed informed consent * ecog score 0 to 2 exclusion criteria: * contra-indication to ifn * transcripts other than m-bcr * pregnancy, lactation * hiv positivity, chronic hepatitis b or c. * prior or concurrent malignancy other than cml (exceptions to be mentioned) * history of arterial occlusive disease or (peripheral, carotids or severe coronary heart disease). * permanent elevation of total cholesterol and triglycerides despite treatment * severe psychiatric/neurological disease (previous or ongoing) * concomitant auto-immune disease * other investigational product ongoing * ongoing immunosuppressive treatment * ongoing treatment at risk for inducing torsades de pointes * qtcf \> 450ms despite correction of predisposing factors (i.e electrolytes...) * congenital long qtcf * unstabilised thyroid disorder * no health insurance coverage

Keywords: peg-ifn, nilotinib, mr4.5, cml, chronic phase, first-line